NCT06628453Recruiting
CGM for Management of Type 2 Diabetes in Pregnancy
Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 564 (estimated)
- First submitted
- 25 Sept 2024
- Start date
- 8 Apr 2025
- Primary completion date
- Feb 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Type 2 diabetes
- NCT number
- NCT06628453
What you commit to
- Study type: Interventional
- Planned participants: 564
- From 8 Apr 2025 to the primary completion date, Feb 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in this trial in a previous pregnancy
Other illness
- Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions
Other
- Multiple gestation
- Major fetal anomaly or two or more minor fetal anomalies
- Planned delivery outside study consortium
- Participating in another conflicting interventional study
- Patient unable to consent
- Physician refusal for other reasons
Who the study is looking for
- Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater
- Pregnant with viable fetus at 6 to less than 23 weeks gestation
- Maternal age 18-50 years old
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Prisma Health Greenville Memorial Hospital Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of California At San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.